510(k) K933178

GDC 3509 by Deringer-Ney, Inc. — Product Code EJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1993
Date Received
June 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type